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Mission Statement
To provide
our clients with unsurpassed technical expertise in start-up, commissioning,
validation, quality assurance, and regulatory consultation in order
to successfully meet their needs in accordance with their schedule demands
and budgetary requirements.
Background
GL Consulting
Company was formed in 1996 by Greg Lynch after leaving a career at a
pharmaceutical company. As a consequence of his experiences as a corporate
employee on several large-scale local and international projects, he
formulated and refined an integrated approach to the management of Engineering-Procurement-Construction-
Validation contracts. He recognized that the approach is widely applicable,
but was rarely used on smaller projects or when multiple contractors
are involved. To maintain flexibility and address the growing needs
of clients, Engineering, Consulting and Validation Services, Inc. (ECVS)
was formed in 1999. ECVS joined a cooperative partnership of several
like minded companies to provide specialized, targeted capabilities
to the pharmaceutical/biopharmaceutical industry.
Since the large consulting companies focused on the large projects while
staffing contract validation personnel and the small companies desired
only to supply manpower, no company was positioned to adapt the expertise
and skills acquired on the large jobs to a wider array of validation
projects. Engineering, Consulting and Validation Services was created
with this objective in mind. As a testament to this new approach, ECVS
partnered with a consortium of companies after September 11, 2001 in
the successful rapid response to construct and validate a dedicated
BL-2 facility to replenish the US smallpox vaccine supply.
Our Philosophy
ECVS has chosen its staff to reflect the requirements of an integrated
engineering and validation program. The “core” group of
project managers and senior consultants has experience in all aspects
of engineering, validation, and quality systems. These “core”
individuals have demonstrated the ability to execute the integrated
philosophy and coordinate the activities of all disciplines to ensure
a successful validation effort. Whether it is the execution of a single
validation protocol, or multi-protocol execution from process development
to the Pre-Approval Inspection, the development of a regulatory compliance
action plan, or the ongoing validation of a production facility, the
key to a successful project is the recognition by all disciplines
of the importance of incorporating regulatory requirements into the
project from the start.
ECVS partners also understand that the pharmaceutical industry is
a worldwide business. Whether a company has international suppliers,
operations, or customers, the engineering and validation group must
be constantly aware of the vast array of international regulations
and current Good Manufacturing Practices.
ECVS recognizes that only a service organization capable of providing
consistent quality will survive in the aggressive consulting business.
ECVS has based its hiring practices on finding those individuals who
are motivated self-starters with proven skills in the industry.
Our Team
Our Partners
QVS, Inc.
AVST, Inc.
Water Dynamics Co.
CERTS, Inc.
MKCS Automation, Inc
Compliance Team, Inc.
CGMP Solutions, Inc.
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